Australia: TGA Introduces Manufacturer Evidence Guidance for IVD Medical Devices Manufacturers

On June 20, 2023, the Therapeutic Goods Administration (TGA) released new requirements guidance to help manufacturers adopt the annulment of ISO 13485 certification. TGA allows for different types of manufacturing evidence to be used to support ARTG IVD entry, including TGA Conformity Assessment, Medical Device Single Audit Programme Certification (MDSAP), EU IVDR, ISO 13485, and EC IVDD. However, 70% of ARTG IVD entries have been supported by ISO 13485 certificates and the phase-out of ISO 13485 certification would impact these entries.

Other types of manufacturer evidence that will be affected by the transition, in addition to entry supported by ISO 13485 certification, include EU IVDD certification and ISO 13485 certification with EU Declaration of Conformity. However, any entries that are also supported by other valid certifications that are accepted by TGA are not required to transition to EU IVDR certification.

TGA has provided a transition timeline for any manufacturer evidence types affected by the ISO 13485 phased-out. The manufacturers may alert on the following manufacturer evidence cut-off date by the TGA.

Credit timetable to TGA

The transition of manufacturer evidence from ISO 13485 to another may require notification action by the manufacturer or sponsor to notify TGA of any changes or ensure regulatory compliance. The manufacturer or sponsor should take note of the actions that might need to be done while transitioning IVD medical devices ARTG entries.

• If sponsors or manufacturers affirm the related IVD medical devices entry involved in the transition phase, the concerned parties may update the manufacturer evidence associated with the new certification. The manufacturers can choose to update partially or all entries at once.

• If there is a lapsing period or certification loss under existing ARTG entry, the manufacturer must notify TGA within 60 days. Criminal or civil sanctions will be imposed if the manufacturer fails to notify TGA about the lapsing, revocation, suspension, or cancellation of the conformity assessment evidence.

• For any potential changes involving the classification of IVD medical devices, the manufacturer has to apply for a new application for inclusion in the ARTG.

• Manufacturers reserve the right to update their ARTG entries via the 'Device Change Request' application if changes need to be made from: incomplete information, a change in the intended use of the medical device, a change in the GMDN code, a change in the manufacturer's legal entity, or a link in his ARTG entry to the manufacturer's new evidence identifier.

• Importing, exporting, or supplying IVD medical devices that do not conform with the Essential Principle would require consent under the transition of manufacturer evidence. If the IVD medical devices do not meet the Essential Principles but are manufactured under legal manufacturer evidence, the sponsor must submit a consent application before any importing, exporting, or supplying of medical devices may occur. TGA will review periodically to ensure the medical devices obey the regulation.

• Compulsory to notify the TGA if there is a safety or performance issue occurs involving the IVD medical devices on the market.

• For any device changes that not affecting the classification with an EU IVDR certification, the sponsor does not have to notify the TGA. While for IVD medical devices with TGA conformity assessment, sponsors have to apply for TGA conformity assessment certificate changes. For other entries supporting certification, compulsory to notify TGA about the changes through Device Change Request (DCR).

• A new inclusion application is required for supplying new devices under Class 4 IVD medical devices. For non-TGA or non-IVDR certification devices must notify TGA through the IVD variation application. For EU IVDR certification devices, no application is required to supply new devices under the same ARTG entry.

Source: Therapeutic Goods Administration (TGA)

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